MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 60-IN STANDARDBORE EXT SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	ME2068
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter zip: (b)(6).Investigation summary: a complaint of a set not being assembled with clamps was received from the customer.One unopened sample was received from the customer.Through visual inspection, the customer complaint was not confirmed.No clamps were present on the set.However this set is not manufactured with clamps per the assembly drawing.No other defects/ damages observed.A device history record review for model me2068 lot number 20066073 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 23jun2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A root cause could not be determined as there was no defect on the product.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.A root cause could not be determined as there was no defect on the product.
Event or Problem Description
It was reported that the 60-in standardbore ext set experienced a missing roller clamp.The following information was provided by the initial reporter: sets did not come with clamps.

• Brand Name: 60-IN STANDARDBORE EXT SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• MDR Report Key: 12173240
• Report Number: 9616066-2021-51513
• Device Sequence Number: 13826086
• Product Code: FPA
• UDI-Device Identifier: 50885403236295
• UDI-Public: 50885403236295
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 06/23/2025
• Device Model Number: ME2068
• Device Catalogue Number: ME2068
• Device Lot Number: 20066073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1